Drug Enforcement D-685-2014

Labeling:Label Mixup; BENZOCAINE/MENTHOL Lozenge, 15 mg/3.6 mg may be potentially mislabeled as LUBIPROSTONE, Capsule, 24 mcg, NDC 64764024060, Pedigree: AD21811_1, EXP: 5/1/2014; LOSARTAN POTASSIUM, Tablet, 50 mg, NDC 00093736598, Pedigree: W003268, EXP: 6/17/2014.

Status

Terminated

Classification

Class II

Report Date

January 22, 2014

Termination Date

February 7, 2014

Product Information

Product description
BENZOCAINE/MENTHOL Lozenge, 15 mg/3.6 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63824072016
Product quantity
80 Lozenges
Reason for recall
Labeling:Label Mixup; BENZOCAINE/MENTHOL Lozenge, 15 mg/3.6 mg may be potentially mislabeled as LUBIPROSTONE, Capsule, 24 mcg, NDC 64764024060, Pedigree: AD21811_1, EXP: 5/1/2014; LOSARTAN POTASSIUM, Tablet, 50 mg, NDC 00093736598, Pedigree: W003268, EXP: 6/17/2014.
Recall initiation reason
Initial firm notification
Telephone
Distribution pattern
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Location & Firm

Recalling firm
Aidapak Services, LLC
Address
14301 Se 1st St

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-685-2014
Event ID
65707
Recall initiation date
July 2, 2013
Center classification date
January 16, 2014
Code info
BENZOCAINE/MENTHOL, Lozenge, 15 mg/3.6 mg has the following codes Pedigree: AD21811_4, EXP: 5/1/2014; Pedigree: W003273, EXP: 6/17/2014.
More code info